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510(k) Data Aggregation

    K Number
    K101669
    Device Name
    THERMODILUTION CATHETER
    Manufacturer
    BIOSENSORS INTL. PTE. LTD.
    Date Cleared
    2010-07-01

    (17 days)

    Product Code
    DQO, DOO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOSENSORS INTL. PTE. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Biosensors flow-directed Thermodilution catheters are designed for use in critical care patients to measure cardiac output, right atrium, pulmonary artery and pulmonary capillary wedge pressures; continuously monitor pulmonary artery temperature, sample blood, intravenously administer drugs and solution and measure cardiac output via the cardiac output computers which interface with 14 kilo-ohms catheters. Different models are available for use in pediatric and adult patients. The tips of the catheters are mounted with a latex balloon which, when inflated, protects the heart tissues from the product's tips during insertion; utilizes blood flow to direct the catheter tip through the right ventricle into the pulmonary artery.
    Device Description
    Biosensors flow-directed Thermodilution catheter is fabricated from extruded tubing, connected to a hub carrying 4 or 5 lumens. The total length of cather of 90 or 110 cm. The extensions include a proximal, a distal, a thermistor and an inflation extension, where the distal end of the inflation extension ends with a tip mounted with a balloon.
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    K Number
    K083384
    Device Name
    THERMODILUTION CATHETER
    Manufacturer
    BIOSENSORS INTL. PTE. LTD.
    Date Cleared
    2010-01-05

    (414 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOSENSORS INTL. PTE. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Biosensors flow-directed Thermodilution catheters are designed for use in critical care patients to measure cardiac output, right atrium, pulmonary artery and pulmonary capillary wedge pressures; continuously monitor pulmonary artery temperature, sample blood, intravenously administer drugs and solution and measure cardiac output via the cardiac output computers which interface with 14 kilo-ohms catheters. Different models are available for use in pediatric and adult patients. The tips of the catheters are mounted with a latex balloon which when inflated, protects the heart tissues from the product's tips during insertion; utilizes blood flow to direct the catheter tip through the right ventricle into the pulmonary artery.
    Device Description
    Blosensors flow-directed Thermodilution catheter is fabricated from extruded tubing, connected to a hub carrying 4 or 5 lumens. The total length of catheter is either of 90 or 110 cm. The extensions include a proximal, a distal, a thermistor and an inflation extension, where the distal end of the inflation extension ends with a tip mounted with a balloon.
    Ask a Question

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